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Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067) (SATISFACTION)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727259
First Posted: August 1, 2008
Last Update Posted: April 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.

Condition Intervention
Hepatitis C, Chronic Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months [ Time Frame: The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment. ]
    Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).


Enrollment: 1995
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with chronic hepatitis C
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b will be administered according to the products' labeling.
Other Names:
  • PegIntron
  • PegPen
Drug: Ribavirin (SCH 18908)
Ribavirin will be administered according to the products' labeling.
Other Name: Rebetol

Detailed Description:
Enrollment of patients will occur in a sequential order of treatment initiation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.
Criteria

Inclusion Criteria:

  • Adult patients with hepatitis C

Exclusion Criteria:

  • According to the products' labeling.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727259


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Clinical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727259     History of Changes
Other Study ID Numbers: P04067
First Submitted: July 30, 2008
First Posted: August 1, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: April 29, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs